Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit

Active Implantable Bone Conduction Hearing System

Cochlear Americas

The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Cochlear Osia 2 System, Cochlear Osia Osi200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear Mri Kit.

Pre-market Notification Details

Device IDK220922
510k NumberK220922
Device Name:Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit
ClassificationActive Implantable Bone Conduction Hearing System
Applicant Cochlear Americas 10350 Park Meadows Drive Lone Tree,  CO  80124
ContactSamata Veluvolu
CorrespondentSamata Veluvolu
Cochlear Americas 10350 Park Meadows Drive Lone Tree,  CO  80124
Product CodePFO  
CFR Regulation Number874.3340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-31
Decision Date2022-07-27

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